FDA accepts NDA for combined diabetes drug

WILMINGTON, Del. The Food and Drug Administration has accepted an approval application for a combination pill for Type 2 diabetes from Bristol-Myers Squibb and AstraZeneca, the two companies announced Wednesday.

Bristol and AstraZeneca submitted the application for extended-release tablets combining saxagliptin and metformin hydrochloride. Saxagliptin is marketed under the brand name Onglyza, while metformin is widely available as a generic.

The companies said the application, filed in late December, was based on a late-stage clinical trial that included studies of co-administration of Onglyza and immediate-release metformin.